The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01913613
Recruitment Status : Completed
First Posted : August 1, 2013
Last Update Posted : July 18, 2018
Information provided by (Responsible Party):
Corvia Medical

July 30, 2013
August 1, 2013
July 18, 2018
September 2013
December 2015   (Final data collection date for primary outcome measure)
MACCE [ Time Frame: 6 months ]
subjects who experience major adverse cardiac and cerebrovascular events (MACCE) defined as death, stroke, MI; or subjects who experience a systemic embolic event (excluding pulmonary thromboembolism)
Same as current
Complete list of historical versions of study NCT01913613 on Archive Site
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REDUCE LAP-HF TRIAL: A Study to Evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Heart Failure
Device: IASD
IASD device implantation
Experimental: Treatment
Treatment with the IASD device
Intervention: Device: IASD

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
July 2018
December 2015   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  1. Chronic symptomatic Heart Failure (HF) documented by one or more of the following:

    1. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
    2. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
    3. On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
  2. Age ≥ 40 years old
  3. Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
  4. Elevated left ventricular filling pressures with a gradient compared to CVP documented by :

    1. PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
    2. PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg

Key Exclusion Criteria:

3. Severe heart failure defined as:

  1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
  2. Fick Cardiac Index < 2.0 L/min/m2
  3. Requiring inotropic infusion (continuous or intermittent) within the past 6 months
  4. Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis >70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Czechia,   Denmark,   France,   Germany,   Netherlands,   New Zealand,   Poland,   United Kingdom
Czech Republic,   Greece,   India,   Israel
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Corvia Medical
Corvia Medical
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Study Chair: Jan Komtebedde, DVM Corvia Medical
Corvia Medical
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP